Quick answers
- What is Plerixafor used for?
- The FDA-approved label (Mozobil, Sanofi-Aventis U.S. LLC, September 22, 2025) says: “Mozobil is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Plerixafor have a boxed warning?
- No. None of the 13 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Plerixafor?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated March 13, 2026). Ask your pharmacist about alternatives.
- Has Plerixafor been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started September 1, 2016 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Plerixafor?
- 13 companies list prescription products of Plerixafor in the FDA NDC Directory, including Bryant Ranch Prepack, Novadoz Pharmaceuticals LLC and Fresenius Kabi USA, LLC.
What Plerixafor is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Mozobil is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM). …
— FDA label: Mozobil, Sanofi-Aventis U.S. LLC, effective September 22, 2025. Read the full label on DailyMed →
The FDA has 13 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 13 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Solution · Injection |
|---|---|
| Route | Subcutaneous |
| Prescription products | 13 in the FDA NDC Directory |
| Brand names | Mozobil |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack1 product
- Novadoz Pharmaceuticals LLC1 product
- Fresenius Kabi USA, LLC1 product
- Zydus Lifesciences Limited1 product
- Eugia US LLC1 product
- Sanofi-Aventis U.S. LLC1 product
- Sagent Pharmaceuticals1 product
- Amneal Pharmaceuticals LLC1 product
- Meitheal Pharmaceuticals Inc.1 product
- Dr. Reddy's Laboratories Inc.1 product
- Camber Pharmaceuticals, Inc.1 product
- Zydus Pharmaceuticals USA Inc.1 product
- Gland Pharma Limited1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022311 MOZOBIL | Genzyme | December 15, 2008 | 11, latest September 21, 2023 2023: Labeling · 2020: Labeling · 2019: Labeling |
Generic approvals (8)
- ANDA205182DR Reddys · July 24, 2023
- ANDA211901Msn · July 24, 2023
- ANDA213672Eugia Pharma · July 24, 2023
- ANDA215334Amneal · July 24, 2023
- ANDA215698Meitheal · July 24, 2023
- ANDA208980Zydus Pharms · July 26, 2023
- ANDA206644Gland · May 3, 2024
- ANDA217560Hetero Labs Ltd Vi · June 16, 2025
Shortage status
To be discontinued · updated March 13, 2026 · first posted March 13, 2026
| Product | Plerixafor, Injection, 24 mg per 1.2 mL (20 mg per mL) (NDC 65219-284-12) |
|---|---|
| Company | Fresenius Kabi USA, LLC |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
September 1, 2016 · Class III · Terminated · D-0704-2017
Labeling: Incorrect or Missing Package Insert
Mozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx Only, Manufactured by: Genzyme Corporation 500 Kendall Street, Cambridge, MA 02412 USA NDC: 0024-5862-01 — Sanofi-Aventis U.S. LLC
-
August 4, 2016 · Class III · Terminated · D-1518-2016
Labeling: Incorrect or Missing Lot and/or Exp. Date
Mozobil (plerixafor injection) 24 mg/1.2 mL (20 mg/mL) per vial, Rx Only, For Subcutaneous Injection only, Manufactured by: Genzyme Corporation, 500 Kendall Street, Cambridge, MA 02142 A Sanofi Company Country of Origin — Genzyme Corporation / Genzyme Biosurgery
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 828700, 828703 |
|---|---|
| SPL set ID of the quoted label | 0ed08d2b-5051-46b2-aa37-1d6275bf9003 |
| FDA labels (SPL) | 13 |
| FDA applications | NDA022311, 8 ANDA |
| Active ingredients (FDA) | PLERIXAFOR |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Mozobil, Sanofi-Aventis U.S. LLC, effective September 22, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →